奥美拉唑肠溶胶囊的质量评价
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摘要
目的:评价奥美拉唑肠溶胶囊的总体质量和现行质量标准的可行性。方法:依照现行法定标准对奥美拉唑肠溶胶囊进行检验,评价其质量状况。结果:本次评价性抽样共检验奥美拉唑肠溶胶囊51批,按现行法定标准检验,全部合格。结论:通过评价发现,奥美拉唑肠溶胶囊按现行标准检验总体质量良好。总结本次工作,提出药品质量评价侧重于释放度、有关物质,以及从源头规避风险的新思路。为提高检验效率,适应快检的要求对含量测定方法进行改进。
Objective: To evaluate the quality of Omeprazole enteric-coated capsules and the feasibility of the current quality standards. Methods: According to the current statutory standards, the quality of Omeprazole enteric-coated capsules was tested and evaluated. Results: Totally 51 batches of the capsules were tested in this evaluating inspection and all were qualifi ed according to the current statutory standards. Conclusion: The overall quality of the capsules tested was good according to the current inspection standards. In addition, drug quality evaluation should emphasize new approaches such as focusing on dissolution and related substance, avoidance of risks from the sources, etc. And the methods of content determination should be improved for the sake of rapid inspection so as to improve inspection effi ciency.
Objective: To evaluate the quality of Omeprazole enteric-coated capsules and the feasibility of the current quality standards. Methods: According to the current statutory standards, the quality of Omeprazole enteric-coated capsules was tested and evaluated. Results: Totally 51 batches of the capsules were tested in this evaluating inspection and all were qualifi ed according to the current statutory standards. Conclusion: The overall quality of the capsules tested was good according to the current inspection standards. In addition, drug quality evaluation should emphasize new approaches such as focusing on dissolution and related substance, avoidance of risks from the sources, etc. And the methods of content determination should be improved for the sake of rapid inspection so as to improve inspection effi ciency.
引文
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[10]黄海,朱莹,徐万魁,等.奥美拉唑肠溶胶囊有关物质检查方法研究[J].中国药事,2011,25(3):276-278.
[11]马云云,王智磊.制剂药品中盐酸雷尼替丁含量测定方法的优化[J].化学分析计量,2014,23(3):71-73.
[12]陈瑞章,胡江滨.药品弹性标准初探:对比分析中美两国药典奥美拉唑肠溶胶囊标准[J].中国药学杂志,2010,45(17):1297-1300.
[13]马云云,谭金峰,徐玉文,等.液相色谱高分辨质谱法测定壮阳类保健品中非法添加物[J].理化检验:化学分册,2015,51(3):1307-1312.
[14]王琳,余倩,张喆,等.硝酸甘油片有关物质方法的辅料扣除及质谱定性研究[J].药物分析杂志,2013,33(11):1953-1957.
[15]中国安全生产协会.安全评价教程[M].北京:中国劳动社保出版社,2010:130-145.
[16]于世林.高效液相色谱方法及应用[M].北京:化学工业出版社,2006:29-29.
[2]李晶.奥美拉唑肠溶胶囊的药理学和不良反应[J].中外医疗,2009,10:105-105.
[3]袁晓琼,杨辉,周远大.国产与进口奥美拉唑肠溶胶囊在健康人体内的药代动力学和生物等效性研究[J].中国药业,2010,19(13):14-15.
[4]王旭,李美珍,卢欣,等.三种HPLC色谱条件下测定奥美拉唑含量方法的比较[J].天津医科大学学报,2012,18(4):510-513.
[5]国家药典委员会.中国药典第一增补本[M].北京:中国医药科技出版社,2012:500-500.
[6]USP32/NF27:Vol 3[S].2009:5978-5981.
[7]オメプラゾール腸溶錠[S]//日本药局方编辑委员会.日本药局方.2012:2461-2462.
[8]徐万魁,岳青阳,潘阳.奥美拉唑肠溶胶囊生产质量风险评价系统的建立[J].中国药物警戒,2011,8(2):97-99.
[9]孔令锋,康强,施法,等.GC-MS法测定奥美拉唑肠溶胶囊中17种邻苯二甲酸酯类[J].药物分析杂志,2013,33(10):1743-1747.
[10]黄海,朱莹,徐万魁,等.奥美拉唑肠溶胶囊有关物质检查方法研究[J].中国药事,2011,25(3):276-278.
[11]马云云,王智磊.制剂药品中盐酸雷尼替丁含量测定方法的优化[J].化学分析计量,2014,23(3):71-73.
[12]陈瑞章,胡江滨.药品弹性标准初探:对比分析中美两国药典奥美拉唑肠溶胶囊标准[J].中国药学杂志,2010,45(17):1297-1300.
[13]马云云,谭金峰,徐玉文,等.液相色谱高分辨质谱法测定壮阳类保健品中非法添加物[J].理化检验:化学分册,2015,51(3):1307-1312.
[14]王琳,余倩,张喆,等.硝酸甘油片有关物质方法的辅料扣除及质谱定性研究[J].药物分析杂志,2013,33(11):1953-1957.
[15]中国安全生产协会.安全评价教程[M].北京:中国劳动社保出版社,2010:130-145.
[16]于世林.高效液相色谱方法及应用[M].北京:化学工业出版社,2006:29-29.